rmn rpr-2004

Nehru,AERBNehru,AERB

Atomic Energy (Radiation Protection) Rules, 2004.

R.M.Nehru Ph.D.,Information and Technical Services DivisionAtomic Energy Regulatory BoardMumbai-400 094

[email protected]


Atomic Energy (Radiation Protection) Rules, 2004.

Rule-3. Licence:-

(1) No person shall, without a licence – (a) establish a radiation installation for siting, design, construction, commissioning and operation; and (b) decommission a radiation installation.

(2) No person shall handle any radioactive material, or operate any radiation generating equipment except in accordance with the terms and conditions of a licence.

(3) A licence shall be issued for sources and practices associated with the operation of -

(vi) telegamma and accelerators used in radiotherapy;(vii) computed tomography (CT) unit;(viii) interventional radiological x-ray unit;

(x) such other source or practice as may be notified by the competentauthority, from time to time.


Authorization shall be necessary provided that for sources and practices associated with the operation of –

(i) brachytherapy;

(ii) deep x-ray units, superficial and contact therapy x-ray units;

(iii) gamma irradiation chambers;

(iv) nuclear medicine facilities;

(v) facilities engaged in the commercial production of nucleonic gauges and consumer products containing radioactive material; and

(vi) such other source or practice as may be notified by the competentauthority, from time to time.


Registration shall be necessary provided further that for sources and practices associated with the operation of –

(i) medical diagnostic x-ray equipment including therapy simulator;

(ii) analytical x-ray equipment used for research;

(iii) nucleonic gauges;

(iv) RIA laboratories;

(v) radioactive sources in tracer studies;

(vi) biomedical research using radioactive material; and

(vii) such other source or practice as may be notified by the competent authority, from time to time.


Consent shall be necessary provided also that for –

(i) approval for siting, design, construction, commissioning and decommissioning of a radiation installation;

(ii) approval for sealed sources, radiation generating equipment and equipment containing radioactive sources, for the purposes of manufacture and supply;

(iii) approval for package design for transport of radioactive material;

(iv) approval for shipment approval for radioactive consignments; and

(v) such other source or practice as may be notified by the competent authority, from time to time.


Rule-5. Exemption:- The use and disposal of an substance and materials which spontaneously emit radiation not exceeding the level of radiation prescribed by notification issued under clause (i) of Sub-Section (1) of Section 2 of the Act and the use of radiation generating equipment, devices or appliances emitting radiation not exceeding the limit determined by the Central Government under clause (g) ofSection 3 of the Act, are exempted from the purview of rule 3.

Rule-6. Exclusion:- Exposures resulting from naturally occurring radionuclides present in the human body, cosmic radiation at the earth surface, unmodified concentrations of radionuclides in raw materials and from other sources and practices which may be prescribed as not amenable for control, are excluded from these rules.


Rule-7. Conditions precedent to the issuance of a licence:-

(1) An application for licence shall be made by to the competent authority by an employer or a person duly authorized by him.

(2) No licence to handle radioactive material, or to operate radiation generating equipment, shall be issued to a person unless, in the opinion of the competent authority -

(a) the application for such licence is for purposes envisaged by the Act;

(b) documentation relevant to the licence and complete in all respects is submitted to the competent authority;

(c) in respect of approval for siting, design, construction, commissioning and decommissioning, of a radiation installation, the proposed equipment, facilities and handling procedures afford adequate protection during normal or intended operations;

(d) the applicant has demonstrated compliance with the provisions of the relevant safety codes and safety standards specified by the competent authority.


Rule-8. Issuance of licence:- The licence shall be issued within a period of one hundred and eighty days from the date of receipt of the application subject to the condition that all the requirements for issuance of the licence have been duly fulfilled.

Rule-9. Period of validity of Licence:- Every licence issued under rule 3 shall, unless otherwise specified, be valid for a period of five years from the date of issue of such licence.

Rule-10. Suspension, modification or withdrawal of a licence:- The competent authority may -

(i) if in its opinion, the licensee has contravened any of the provisions of these rules; or

(ii) considers it to be necessary in public interest pertaining to radiation safety.


Rule-11. Modification of radiation installation or change in working condition:-

No modification to an existing radiation installation or no change in working conditions therein, affecting safety shall be done without the prior approval of the competent authority.

Rule-12. Restrictions on use of sources:-

(1) The licensee shall not handle any source:-(a) other than those specified in the licence;(b) for any purpose other than those specified in the licence;

and(c) in any location except as specified in the licence.

(2) The licensee shall ensure that individuals other than those who may be specified in the licence do not handle the source.


Rule-14. Radiation symbol or Warning sign:-

(1) The radiation symbol or warning sign shall be conspicuously and prominently displayed at all times –

(a) on externally visible surfaces of radiation equipment, and containers for storage of radioactive materials; packages for radioactive materials and vehicles carrying such packages;

(b) at the entrance to the room housing the radiation generating equipment; and

(c) at the entrance of controlled area and supervised area.

(2) The radiation symbol shall not be used for any purpose other than those mentioned in these rules.

(3) The specification of the radiation symbol or warning sign shall be asprescribed by the competent authority, by order for that purpose.


Rule-15. Dose limits and other regulatory constraints:-

The licensee shall ensure compliance with the dose limits and other regulatory constraints specified by the competent authority by order under these rules.

Rule-16. Safety Standards and Safety Codes:-

The competent authority may issue safety codes and safety standards, from time to time, prescribing the requirements for radiation installation, sealed sources, radiation generating equipment and equipment containing radioactive sources, and transport of radioactive material and the licensee shall ensure compliance with the same.


Rule-17. Prohibition of employment of persons below certain age:-

(1) No person under the age of 18 years shall be employed as a worker.

(2) No person under the age of 16 years shall be taken as trainee or employed as an apprentice for radiation work.

Rule-18. Classified worker:-

The employer shall designate as classified workers, those of his employees, who are likely to receive an effective dose in excess of three tenths of the average annual dose limits notified by the competent authority and shall forthwith inform those employees that they have been so designated.


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Rule-23. Responsibilities of worker:-

(1) Every worker shall observe the safety requirements and follow safety procedures and instructions and shall refrain from any willful actthat could be detrimental to self, co-workers, the radiation installation and public.

(2) The worker shall:-(a) provide to the employer information about his previous occupations including radiation work, if any;(b) make proper use of such protective equipment, radiation monitors and Personnel monitoring devices as provided; and(c) inform the licensee and the Radiological Safety Officer, of any accident or potentially hazardous situation that may come to his notice;

(3) A female worker shall, on becoming aware that she is pregnant, notify the employer, licensee and Radiological Safety Officer in order that her working conditions may be modified, if necessary.


Rule-24. Records of workers:-

(1) Every licensee shall maintain complete and up-to-daterecords of -

(a) personnel monitoring under Clause (b) of sub-rule (2) of rule 27, in the format as specified by order by the

competent authority; and(b) the health surveillance specified in rule 25.

(2) Such records shall be preserved during the working life of each worker, andafterwards until the worker attains or would have attained the age of Seventy fiveyears, or not less than thirty years after the termination of the work involving occupational exposure whichever is later.

(3) A worker shall have access to his personnel monitoring and the health surveillance records.


Rule-25. Health surveillance of workers:-

(1) Every employer shall provide the services ofa physician with appropriate qualifications to undertake occupational health surveillance of classified workers.

(2) Every worker, initially on employment, and classified worker, thereafter at least once in three years as long as the individual is employed, shall be subjected to the following -

(a) general medical examination as specified by order by the competent authority;and(b) health surveillance to decide on the fitness of each worker for the intended task;

(3) The health surveillance shall include -(a) special tests or medical examinations as specified by order by the competent authority, for workers who have received dose in excess of regulatory constraints; and

(b) counseling of pregnant workers.


Rule-26. Medical exposures:-

The licensee carrying out diagnostic or therapeutic workusing radiation generating equipment, sealed or unsealed sources, shall for optimizing the medical exposure ensure that -

(a) performance of the equipment is verified periodically by appropriate quality assurance tests;

(b) records are maintained for a period specified by the competent authority.


Rule-27. Radiation surveillance requirements:-

(1) The competent authority may by order specify appropriate radiation surveillance requirements and procedures and the employer and the licensee shall comply with them.

(2) Without prejudice to the generality of the foregoing provisions, such radiation surveillance requirements and procedures may provide that -

(a) the siting, design, construction, commissioning, operation, servicing and maintenance and decommissioning of facilities involving the use ofradiation, and disposal of radioactive material shall be done in accordance with the specifications laid down by the competent authority in the relevant safety codes and safety standards;

(b) the workers shall be subjected to personnel monitoring and healthsurveillance and appropriate records shall be maintained;

(c) transport of radioactive material in public domain shall be in accordance with the procedures laid down by the competent authority and in accordance with the other regulations pertaining to transport by different modes.


Rule-28. Directives in the cases of exposures in excess of regulatory constraints:-

(1) When, in the opinion of the competent authority, any worker has exceeded the dose constraints, the competent authority may, without prejudice to other course of action available, issue appropriate directives for controlling further exposure and the employer shall comply with the directives.

(2) If a worker discontinues radiation work under the directives of the competentauthority issued under this rule, the employer shall assign alternative work notinvolving exposure to radiation, until the competent authority is satisfied about the fitness of the worker to resume radiation work.

(3) The employer shall comply with restrictions, if any, that the competent authority may impose in this regard.


Rule-29. Power to appoint or recognize persons or agencies:-

The competent authority may, from time to time, appoint or recognize persons or agencies having the qualifications and expertise, prescribed in the relevant safety code, for the purpose of performing any of the functions entrusted to them by the authority and for ensuring compliance with radiological surveillance.


Rule-30. Inspection of premises, radiation installations and conveyances:-

(1) Any person duly authorised under sub-Section (4) of Section 17 of the Act may, for the purposes of enforcement of these rules, inspect any premises, or radiation installation, or conveyance.

(6) The person authorised to conduct inspection may -

(a) Inspect, from safety point of view, to ensure that the licensee has fulfilled the radiological safety requirements for carrying out the practices at the radiation installation as per the stipulations laid down in the licence.


Rule-31. Power to investigate, seal or seize radiation installation or radioactive material and to give direction to the employer:-

Rule-32. Directives in case of accidents:-

(1) In the event of an accident involving the source or release of radioactive material, the competent authority may –

(a) Intervene and issue such directions as deemed fit and proper under the circumstances in the interest of radiation safety and the employer shall act as per the directions of the competent authority and shall make every effort tomitigate the consequences of the accident , or

(b) The competent authority may assign experts to give advice or render assistance in mitigating the consequences of the accident and the expenses incurred, if any, shall be reimbursed by the employer.


Rule-33. Emergency preparedness:-

(1) The licensee shall prepare emergency response plans as specified by the competent authority in the relevant safety codes and maintain emergency preparedness.

(2) The licensee shall submit the response plans for plant emergencies and siteemergencies to the competent authority for approval.

(3) The licensee shall submit the response plans for off-site emergenciesprepared by the appropriate authorities to the competent authority for review.

(4) In respect of radiation installations governed by clause (a) of sub-rule (3) ofrule 3 and clause (b) of sub-rule (3) of rule 3, emergency response plans shall be submitted to the competent authority prior to the commissioning of theinstallations.

(5) Any modification to the emergency plan shall require prior approval of orreview by the competent authority.


Rule-34. Decommissioning of radiation installation:-

(1) When a radiation installation or radiation generating equipment ceases to be in use, the employer shall ensure its decommissioning.

(2) No employer shall decommission a radiation installation without the prior approval of the competent authority.

(3) The decommissioning plan shall take due cognizance of disposal ofradioactive wastes, recycling of materials, and reuse of equipment and premises.

(4) The licensee shall comply with such directive as may be issued by the competent authority to ensure adequate protection of the persons in and around the decommissioned installation.


Rule-35. Offences and penalties:-

Any person who contravenes the provisions of these rules or any of the terms and conditions of licence issued hereunder, shall be punishable as provided for under the Act.


Comparison of RPR-2004 w.r.t. RPR-1971

1. Rule-3 on “License” is expanded and explained in accordance with AERB/SC/G.2. Exposures resulting from naturally occurring radionuclides present in the human body,

cosmic radiation at the earth surface, unmodified concentrations of radionuclides in raw materials and from other sources and practices which may be prescribed as not amenable for control, are excluded from these rules.

3. Conditions precedent to the issuance of a licence is elaborated in accordance with AERB/SC/G.

4. Processing of License period is defined i.e., 180 days. 5. Validity of the License is extended from 3 years to 5 years.6. Age limit on Trainee Worker defined i.e., “No person under the age of 16 years shall be

taken as trainee or employed as an apprentice for radiation work. 7. The concept of “classified workers” is defined as those of his employees, who are likely

to receive an effective dose in excess of three tenths of the average annual dose limits notified by the competent authority.

8. Handlings of luminous compounds are not addressed.9. Not discussed on the handling and ultimate disposal of animal carcasses and foliage

containing radioactive materials and “Autopsies of cadavers containing radioactive materials”

10. Many of the old RPR-1971 Rules are fused together (Only 35 Rules in RPR-2004 when compared to55 Rules in RPR-1971)


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